Quality Assurance Engineer - Med Device

JR United Kingdom; Ipswich; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading medical device company is seeking a Quality Assurance Engineer in Ipswich. The role involves developing the Quality Management System, conducting internal audits, and ensuring compliance with ISO 13485, CAPA, and GMP standards. Ideal candidates will have a relevant degree and practical experience in the industry.

Qualifications

• Proven experience in Quality Systems implementation within the industry.
• Practical knowledge of ISO 13485, CAPA, GDP, and GMP standards.

Responsibilities

• Support the development of the site Quality Management System (QMS).
• Conduct internal quality audits and prepare audit reports.
• Assist in preparation for customer, regulatory, and notified body audits.

Skills

Quality Systems

ISO 13485

CAPA

GDP

GMP

Regulatory Compliance

Internal Audits

Supplier Quality

Education

Relevant degree in a scientific or engineering discipline

Job description

Quality Assurance Engineer - Med Device, Ipswich

Client: Hyper Recruitment Solutions

Location: Ipswich

Job Category: Other

EU work permit required: Yes

Job Views: 1

Posted: 06.06.2025

Expiry Date: 21.07.2025

Job Description:

Role Overview: We are seeking a Quality Assurance Engineer to join a leading medical device company based in the SEERS Medical area. The successful candidate will ensure that products and services are fit for purpose, legally compliant, and meet customer expectations.

Key Duties and Responsibilities:

• Support the development of the site Quality Management System (QMS) to meet business requirements.
• Conduct internal quality audits and prepare audit reports.
• Assist in preparation for customer, regulatory, and notified body audits.
• Provide guidance on non-conformances and support manufacturing operations.

Role Requirements:

• Relevant degree in a scientific or engineering discipline.
• Proven experience in Quality Systems implementation within the industry.
• Practical knowledge of ISO 13485, CAPA, GDP, and GMP standards.

Keywords:

Quality Assurance Engineer, Quality Systems, ISO 13485, CAPA, GDP, GMP, Quality Management System, Medical Devices, Regulatory Compliance, Internal Audits, Supplier Quality

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS specializes in supporting the Life Science sectors, combining recruitment expertise with scientific knowledge to help advance your career.